NEW YORK, Aug 8 (Reuters) - Schering-Plough Corp. said on
Wednesday it won regulatory approval to sell two of its
hepatitis C drugs in a combination package that's expected to
become the new ``gold standard'' of treatment for a disease
that affects 4 million Americans.
The U.S. Food and Drug Administration said the Kenilworth,
New Jersey-based pharmaceuticals company can sell Peg-Intron,
a longer-lasting form of its Intron A drug, in a
single-package combination with its Rebetol drug, also known
The decision follows an FDA ruling last month granting
Schering-Plough the right to sell Rebetol as an individual
product. Previously it could only be sold with Intron A. The
approval allowed doctors for the first time to mix and match
hepatitis C therapies.
The latest FDA ruling enables Schering-Plough to create a
single, branded package combining Rebetol and Peg-Intron, for
which doctors can write a single prescription.
``This approval allows Schering-Plough to control the
process and directly market the combination product,'' said
Steven Tighe, an analyst at Merrill Lynch & Co.
Schering said both Rebetol and Peg-Intron will be available
separately on the market this fall. At that point doctors will
be able to combine them. The company declined to articulate,
however, its marketing plans for the combination package.
The approval gives Schering-Plough a jump on Swiss rival
Roche Holding Ltd. , which has developed a competitor to Peg-Intron
called Pegasys. Roche is expecting the FDA to approve Pegasys
in the U.S. by early next year.
While doctors will be free to prescribe Rebetol with either
Pegasys or Peg-Intron, analysts expect most doctors
will prescribe Schering-Plough's combination, partly because
of the convenience and partly because of the direct marketing
clout Schering-Plough will be able to bring to the table in
selling the drug package to physicians.
Sanford Bernstein analyst Richard Evans predicts that sales
of Schering-Plough's hepatitis C drugs in the U.S. will double
next year to $1.4 billion from $700 million this year.
He predicts global sales will rise 56 percent to $2.5 billion
from $1.6 billion.
Peg-Intron uses proprietary technology developed by Enzon
Inc. Under the company's agreement with Schering-Plough, Enzon
is entitled to royalties on worldwide sales of Peg-Intron.
Schering-Plough licenses ribavirin from ICN Pharmaceuticals
Inc of Costa Mesa, California.
Schering-Plough's shares rose 17 cents, or 0.45 percent,
to close at $38.35 on the New York Stock Exchange. Enzon's
shares rose $4.85, or 8.07 percent, to $64.96 on Nasdaq. ICN's
shares fell 13 cents, or 0.39 percent, to $32.85 on the New